Diaphragm Mobilization With Rotator Cuff Lesions

NCT07086066 | Completed

• 1 other identifier: 61351342/020-827
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The glenohumeral joint is the least restricted joint in terms of mobility compared to other joints in the human body. The rotator cuff is a part of the shoulder complex consisting of four muscles and their tendons, which are responsible for stabilizing the shoulder joint. These muscles are the supraspinatus, infraspinatus, teres minor, and subscapularis. The supraspinatus muscle enables shoulder abduction, infraspinatus and teres minor provide external rotation, and the subscapularis is responsible for internal rotation. The presence of a rotator cuff lesion is the most common cause of shoulder pain. It usually results from the tear, inflammation, or injury of one or more rotator cuff muscles. It is more prevalent in elderly individuals and is characterized by severe shoulder pain, limited range of motion, and functional loss. These symptoms negatively impact the patient's performance and significantly reduce their quality of life. The diaphragm is a large, dome-shaped muscle and the primary muscle of respiration. It is innervated by the phrenic nerve, which is connected to the vagus nerve. During breathing, the diaphragm's movements can directly or indirectly influence the sympathetic and parasympathetic nervous systems, thereby modulating pain perception in the body. Moreover, there is a significant relationship between the shoulder and diaphragm in terms of myofascial connections and neural innervation. Effective functioning of the diaphragm not only contributes to proper respiration but also positively affects spinal mobility and overall posture. It supports the efficiency of upper body structures such as the cervical spine, shoulder, and neck. Proper diaphragmatic function contributes to core stability, which in turn may reduce the load on shoulder structures. Manual techniques targeting the diaphragm can enhance its function, potentially reducing the mechanical load on the shoulder complex, alleviating pain, and improving the patient's overall functional capacity.

Conditions

Rotator Cuff Syndrome

Keywords

pain; range of motion; function

Outcome Measures

Primary Outcomes (3)

• range of motion

  The range of motion will be evaluated using a universal goniometer to measure and document the angles of shoulder flexion, abduction, internal rotation, and external rotation. This instrument allows for reliable and standardized joint angle assessments, contributing to accurate monitoring of mobility improvements throughout the intervention.

  through study completion, an average of 3 months

• subjective pain

  The Visual Analog Scale (VAS) will evaluate heel pain by asking participants to mark their pain level on a 10 cm scale, where 0 means no pain and 10 signifies severe pain, based on their experience over the past week.

  through study completion, an average of 3 months.

• Upper extremity function

  The "Upper Extremity Functional Index" will be used for functional assessment. The Upper Extremity Functional Index is a self-administered questionnaire that measures disability in individuals with upper extremity orthopedic conditions. The questionnaire includes 20 activities, and the patient is asked to rate the difficulty of completing each activity. The scores from the 20 questions are summed to obtain a maximum possible score of 80. The lowest possible score is 0. Lower scores indicate greater difficulty in performing upper extremity activities.

  through study completion, an average of 3 months

Study Arms (2)

Diaphragm mobilization group

EXPERIMENTAL

The experimental group received conventional physical therapy and diaphragm mobilization.

Other: Diaphragm mobilization; Other: conventional physical therapy

standard physiotherapy group

ACTIVE COMPARATOR

The control group will receive only conventional physical therapy.

Other: conventional physical therapy

Interventions

Diaphragm mobilization OTHER

This group underwent treatment three times a week, with each session lasting 40 to 60 minutes, over a period of six weeks. Diaphragm mobilization included techniques aimed at increasing muscle elasticity, improving postural balance, and reducing pain by stimulating the sympathetic and parasympathetic nervous systems. In each session, participants received 20 minutes of TENS and 10 minutes of cryotherapy. Following this, diaphragm mobilization was applied. During the application, participants were positioned comfortably in the supine position. The physiotherapist palpated the diaphragm, instructed the participant in diaphragmatic breathing, and asked them to take a deep diaphragmatic breath. During expiration, the diaphragm was mobilized in the posterior and inferior directions. This mobilization was performed 10 times per session. Following that, posterior glide and inferior glide techniques were performed.

Diaphragm mobilization group

conventional physical therapy OTHER

As with the experimental group, therapy will be delivered three times per week for six weeks, with each session lasting between 40 and 60 minutes. Each session will include 20 minutes of TENS and 10 minutes of cryotherapy, followed by posterior and inferior gliding techniques on the glenohumeral joint and capsular stretching. Functional exercises will also include wand exercises (two sets of 10 repetitions) and finger ladder exercises targeting shoulder flexion and abduction, but without the addition of diaphragm mobilization techniques.

Diaphragm mobilization group; standard physiotherapy group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 25 and 55
• Individuals diagnosed with a rotator cuff injury through radiological methods
• Individuals experiencing severe pain (VAS ≥ 3) and functional loss
• Individuals who are willing to participate in the study and have signed the written informed consent form after understanding the purpose and procedure of the study

You may not qualify if:

• Individuals with a history of rotator cuff surgery
• Individuals with a history of shoulder subluxation
• Individuals with a history of SLAP lesions
• Individuals with respiratory system diseases
• Individuals with nerve damage (e.g., brachial plexus lesions) or neurological disorders that may affect shoulder movements
• Individuals with psychological disorders (e.g., depression, anxiety) that may affect pain perception
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants were unaware of which group they had been assigned to. Based on the order of their arrival at the hospital, those who arrived first, third, fifth, and so on were assigned to the diaphragm mobilization group, while those who arrived second, fourth, sixth, and so on were assigned to the standard physiotherapy group. This allocation method ensured that participants remained blinded to their group assignment, minimizing potential bias in their responses or expectations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Physiotherapist

Model Details: There were two groups in the study. The experimental group received conventional physical therapy combined with diaphragm mobilization. The control group received only conventional physical therapy without diaphragm mobilization.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: March 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

TU (1)